For a number of years ostomy appliances have been available which generally comprise two components, a body-side faceplate assembly, sometimes referred to as body-side wafer or a skin barrier, and a pouch assembly, frequently referred to simply as an ostomy bag. Generally, the body-side faceplate assembly comprises a pad or surgical dressing, a central opening, designed to be adhesively affixed to the skin surface of the user with the stoma passing through the central aperture. The side of the faceplate assembly away from the user is provided with a flange in surrounding relation to the central opening. The ostomy pouch assembly is essentially a waterproof bag affixed with a flanged opening.
The two flanges of the ostomy appliance are matched and mated to provide a coupling between the faceplate assembly and the pouch assembly that will be secure and free of leakage of liquids and gases. U.S. Pat. No. 4,419,100 to Alexander, and U.S. Pat. No. 4,460,363 to Steer and Edwards provide detailed description of both the ostomy appliances and of a variety of coupling flanges that are useful for securing the body-side faceplate assembly and the ostomy pouch assembly to each other. Commercially available examples of these devices include the Hollister Two-piece Ostomy System, manufactured by Hollister Incorporated, Libertyville, Ill., and the Sure-fit System, manufactured by Convatech, a Squibb Company of Princeton, N.J.
While these various ostomy appliances are useful and effective, there is considerable room for improvement in the devices to increase the comfort of the user. In the typical situation, there is a tendency for the stoma to expand in size. As an example, it has been known for the diameter of a stoma to double in size over a period of two years. This requires replacing the central opening in the ostomy faceplate assembly with one of a somewhat larger opening to accommodate the larger stoma. A general discomfort accompanies this expansion of the stoma.
A more serious problem encountered by persons who have had a colostomy and ileostomy or the like is the occurrence of prolapse. During prolapse, there is a tendency for a portion of the organs behind the immediate opening to the stoma to protrude through the open and beyond the stoma. This occurs in a number of ways and in a number of forms but is almost always a matter of substantial discomfort. The only methods known at the present time for relieving prolapse are surgical, usually involving closure of the stoma, and reopening of a stoma at another more suitable location. Temporary relief is frequently obtained by the wearer of the ostomy sevices by placing the hand over the stoma and exerting pressure so as to relieve the effects of the prolapse.
Still another problem encountered by ostomy appliance users results from the pressure of clothing against the exterior of the bag, especially when the ostomy appliance user sits down. The pressure of the clothing against the ostomy bag tends to close off the opening into the bag and/or create a clogging situation.